Description
The Manufacturing Science and Technology (MSAT) Analytical Science Function is a global team supporting GSK’s new product introduction into the market and manufacturing sites with projects aligned to technology transfers, second generation processes and critical investigations with supply impact.
The Analytical Science and Technology Lead (ASTL) is responsible for the leadership and delivery of business-critical projects to support all the analytical aspects related to the late phase of the product lifecycle for key GSK products.
Key Responsibilities:
- Provide technical analytical leadership for programs, projects and activities related to specific products under the ASTL accountability to ensure business priorities and targets are met.
- Be accountable for the Analytical Product strategy (APS), including maintenance and updates through the post-approval product lifecycle.
- Manage and define comparability studies and suitable characterization strategies to support post-approval changes for accountable products.
- Provide analytical input and expertise into comparability protocols and reports.
- Partner with teams across the business in a matrix-fashion to meet asset needs and identify and mitigate risks.
- Ensure that method knowledge is embedded in the onward Technical Transfer to other GSK sites and external sites.
- Drive evaluation of new technologies, including PAT, for analytical testing related to the Product control strategy.
- Support sites by providing expertise for analytical aspects of root cause analysis investigations.
- Defend APS for accountable products during HA inspections.
Requirements:
- Relevant education/qualifications (e.g., BS/MS in a scientific discipline).
- Experience with analytical method development, validation and transfer.
- Experience in the biopharmaceutical industry with relevant experience in late-stage product, Critical Quality Attribute (CQA) assessment.
- Strong understanding of drug substance and drug product dose forms manufacturing disciplines and relationship with analytical testing and control strategy.
- Experience authoring regulatory files.
Location: The successful applicant can be based at Ware (UK) manufacturing site or at Upper Merion (USA) site.
Closing Date: Friday 20th of November 2026 (COB).
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